The present invention is directed generally toward a tissue specimen collection kit with bar code process and audit system for tracking tissue specimens after biopsy.
With the advent of needle and fiberoptic biopsy techniques, tissue specimens have become smaller and more numerous. The tissue is increasingly difficult to recover from specimen jars and harder to preserve. The complicity of operating room routines and laboratory routines makes the probability of specimen mis-identification much higher than in the past. The routines for processing a tissue specimen generally follow a chronology beginning in the operating room and ending in a slide storage room.
Biopsy processing begins in the operating room when the physician excises the tissue from a patient and places it in a temporary storage container having a tissue preservative solution. Various storage containers may be used to temporarily hold the biopsied specimen while it is being prepared for transport for later analysis in the laboratory. The storage containers are usually identified by a patient identification number and name embossed on a label affixed to the side of the storage container. The specimen is listed in a log book in an area near the operating room and left for a person to transport it to the pathology lab. Such identification procedures often invite the possibility of mislabelling or mis-identification of specimens.
The specimen is next taken from the operating room area to a laboratory assistant's area where the specimen is logged into a centralized computer by entering the necessary identification information. Log-in procedures invite opportunity for error if original storage containers have previously been incorrectly labelled. The pathologist's assistant prepares and writes or embosses the identification information on a series of cassettes which will receive the specimen samples. Loose or empty cassettes left on the bench may be accidently swapped or confused with cassettes belonging to other cases.
Next, the pathologist's assistant removes the specimen from the container using a pair of forceps. These methods of specimen retrieval often increase the probability of incompletely recovering or fragmenting the biopsied specimen. Even if a Vabra or similar suction device is used to collect the specimen in the operating room, it is extremely hard to recover all of the tissue for processing. The assistant records and examines the specimen.
The tissue specimens are then placed on a sheet of filter paper which is either placed directly into the cassette or which is sandwiched between a set of thin sponges and then placed into the cassette. The cassette is closed and placed into a bucket of fixative to join other cassettes processed that day.
Cassettes are then carried to a chemical processing area where they are placed into a chemical processing machine. The machine starts its fully automated process which consists of a series of chemical baths and rinses. It completes its task in about three to about ten hours.
After chemical processing the cassettes and specimens are taken to an embedding station. The cassette number, tissue type and number of tissue fragments are matched with log sheet data. The sponges and filter paper are removed and a mold or molds for tissue embedding is selected according to tissue size and shape. This system is often labor intensive, involves risk of tissue loss, damage, misplacement or contamination and specimen identification error.
Molten paraffin or similar embedding medium is poured into the prepared molds. The tissue is oriented with forceps so that its surface will be adequately exposed for microtome cutting. After the specimen and embedding medium cool the specimen-cassette unit "block" is removed from the mold. The "block" is then secured to a microtome fixture in preparation for cross-sectional slicing. The flat "block" surface is exposed so that repeated incremental and cross-sectional slices of the tissue may be made. Commonly, the specimen cross-sections will be sliced either too thick or too thin by the microtome blade. Additional slices are generally necessary to attain correct cross-sectional slice thickness of embedding medium and specimen. Also, many times, repetitive slices are necessary to reach the specimen which is embedded deep within the embedding medium away from the hardened "blocks" surface. Such repetitive slicing will inevitably increase the wear on the microtome blade as well as compromise the precision of other cross-sectional slices processed later in the day. The string of cross-sectional slices are then placed on a water bath to remove any curling of specimen and paraffin caused by the cyclic slicing of the microtome.
After microtome cutting, the string of cross-sectional tissue-paraffin slices are individually placed on marked slides. The remaining paraffin or similar fixative is chemically removed and the specimens are stained and cover-slipped. The slides are then sent from the histopathology staining area to the pathologist for microscopic examination. The remaining slides and paraffin blocks are taken to a file room for storage.
Tissue specimen processing is fiddled with human errors and technical imperfections that significantly reduce the accuracy, efficiency and preservation of specimen. Such imperfections inevitably affect the accuracy of diagnosis by the pathologist. These and other difficulties experienced with the prior art devices have been obviated in a novel manner by the present invention.
It is therefore, an outstanding object of the invention to provide a tissue specimen collection kit which will remove human errors and technical imperfections which significantly reduce the efficiency and accuracy of diagnosis of tissue specimens.
A further object of the present invention is the provision of a tissue specimen collection kit which is simple in construction, which is inexpensive to manufacture and which will reduce amount of labor necessary for processing.
It is another object of the present invention to provide a tissue container which will allow for ease of retrieval of biopsied specimens.
A still further object of the invention is the provision of a bar coding system for ease of identification, tracking and storage of biopsied specimens.
It is a further object of the invention to provide a tissue cassette which will minimize tissue fragmentation or escape, almost eliminate specimen handling and increase tissue yield. It is a still further object of the present invention to provide a tissue cassette having a porous concave surface which will allow for maximum elevation of a specimen to the surface of an embedding "block" for improved cross-sectional slicing.
With these and other objects in view, as will be apparent to those skilled in the art, the invention resides in the combination of parts set forth in the specification and covered by the claims appended hereto.